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Prof. Marc A. Rodwin,
3 credits day; 3 credits evening. Grading based on a mid-term and end of semester exam and on
class participation.
This course focuses on pharmaceutical industry regulation and policy in the United States. It
examines: the Food and Drug Administration process used to approve the sale of drugs;
exclusive marketing arrangements; regulation of clinical trials to evaluate drug safety and
effectiveness; regulation of drug marketing; prescribing drugs for off-label uses; financial and
legal responsibility for drug induced injuries; post-marketing drug safety; drug firm financial
relations with physicians and medical institutions; funding of research and development; pricing
and access to drugs; the relation between U.S. and international drug markets and regulation.
Elective Course
Final Exam Required
E-Commerce and the Law